Effects of concomitant use of prasugrel with edoxaban on bleeding time, pharmacodynamics, and pharmacokinetics of edoxaban in healthy elderly Japanese male subjects: a clinical pharmacology study

Table 1 Study design, schedule for BT, PD, and edoxaban PK evaluations

Subjects	Healthy elderly Japanese male subjects (Age: 65–80)
Study design	Open-label, parallel-group, repeated-dose
Sample size	24 Subjects randomized into two groups
	Group 1, n = 12 30 mg Edoxaban + 2.5 mg Prasugrel	Group 2, n = 12 30 mg Edoxaban + 3.75 mg Prasugrel
Treatments	Stage 1: all participants Day 1, 2, 3: 30 mg Edoxaban once daily
	Stage 2: Day 4, 5, 6, 7, 8 Group 1: 30 mg Edoxaban + 2.5 mg Prasugrel once daily	Stage 2: Day 4, 5, 6, 7, 8 Group 2: 30 mg Edoxaban + 3.75 mg Prasugrel once daily
Schedule of procedures and blood sample collections
Bleeding time (BT)^a& PD Evaluation^b	Day 0: Day of admission Day 3: Three hours after administration of edoxaban Day 8: Three hours after administration of edoxaban + prasugrel
Edoxaban PK	Day 1: Pre-administration of study drug Day 3: Pre-administration and 0.25, 0.5, 1, 2, 3, 4, 8, 12, 24 h after administration of edoxaban Day 8: Pre-administration and 0.25, 0.5, 1, 2, 3, 4, 8, 12, 24 h after administration of edoxaban + prasugrel

^aIvy Method
^bPD indices: prothrombin time (PT), activated partial thromboplastin time (aPTT), prothrombin fragment 1 + 2 (F1 + 2), and P2Y₁₂ reaction units (PRU)

ISSN: 1477-9560